השוואת שיטות

	ניתוח שקילות ביולוגית (שני מבחנים חד-צדדיים)	פרמקוקינטיקה של אוכלוסיות
תחום	פרמקומטריקה	פרמקומטריקה
משפחה	Hypothesis test	Regression model
שנת המקור	1987	1977
הוגה השיטה	Donald J. Schuirmann	Sheiner, Rosenberg & Marathe
סוג	Parametric equivalence test	Nonlinear mixed-effects regression model
מקור מכונן	Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of Pharmacokinetics and Biopharmaceutics, 15(6), 657–680.	Sheiner, L. B., Rosenberg, B., & Marathe, V. V. (1977). Estimation of population characteristics of pharmacokinetic parameters from routine clinical data. Journal of Pharmacokinetics and Biopharmaceutics, 5(5), 445–479.
כינויים	TOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik Analizi	PopPK, Nonlinear Mixed-Effects Modeling, NONMEM Approach, Popülasyon Farmakokinetiği
קשורות	2	2
תקציר	Bioequivalence Analysis is a regulatory-grade statistical framework used to determine whether a test drug formulation (generic or reformulated) delivers the active ingredient to the systemic circulation at a rate and extent comparable to a reference product. Introduced by Donald J. Schuirmann in 1987, the method operationalizes equivalence through the Two One-Sided Tests (TOST) procedure, replacing the ambiguous absence-of-difference paradigm with an explicit equivalence margin evaluated on log-transformed pharmacokinetic endpoints such as AUC and C_max.	Population Pharmacokinetics (PopPK) is a nonlinear mixed-effects modeling framework that characterizes how drugs are absorbed, distributed, metabolized, and eliminated across a patient population, estimating both typical population parameters and the magnitude of between-subject variability. Introduced by Sheiner, Rosenberg, and Marathe in 1977, it enables parameter estimation from sparse, routinely collected clinical data—making it indispensable in drug development, regulatory submissions, and individualized dosing.